Trial · NCT00536601
High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
NCT00536601, Not applicable, Completed, Roswell Park Cancer Institute; results first posted 2021-04-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors. Trials, record NCT00536601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00536601
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
- NCT number
- NCT00536601
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 174 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Nasal Type Extranodal NK/T-cell Lymphoma, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Immunoblastic Large Cell Lymphoma, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor (PNET), Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Intraocular Lymphoma, Nodal Marginal Zone B-cell Lymphoma, Peripheral T-cell Lymphoma, Plasma Cell Neoplasm, Primary Systemic Amyloidosis, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Neuroblastoma, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Multiple Myeloma, Regional Neuroblastoma, Splenic Marginal Zone Lymphoma, Testicular Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific, Waldenström Macroglobulinemia
- Interventions
etoposide, cyclophosphamide, carmustine, melphalan, busulfan, carboplatin, thiotepa, total-body irradiation, autologous hematopoietic stem cell transplantation, autologous-autologous tandem hematopoietic stem cell transplantation
- First posted
- 2007-09-28
- Last updated
- 2021-04-22
- Results first posted
- 2021-04-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years | Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed. |
| Secondary | Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal)) | Up to 100 days after transplantation | Toxicities will be reported using descriptive statistics. |
| Secondary | Response Rate (Complete Remission) | At 100 days | Response rates will be reported using descriptive statistics. |
| Secondary | Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors) | Patients are followed up to maximum of 12 years | Assessed using the product-limit based Kaplan Meier method. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years | Each disease strata presents PFS for each conditioning regimen defined in the protocol | Proportion of participants | NUMBER |
| SECONDARY | Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal)) | Up to 100 days after transplantation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Response Rate (Complete Remission) | At 100 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors) | Patients are followed up to maximum of 12 years | Proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Acute Leukemia | BuCy | 33 | 95% Confidence Interval 0 to 71 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Hodgkin Lymphoma | BuCy | 14 | 95% Confidence Interval 0 to 40 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Non-Hodgkin Lymphoma | BuCy | 22 | 95% Confidence Interval 7 to 38 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Hodgkin Lymphoma | CBV | 43 | 95% Confidence Interval 17 to 69 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Non-Hodgkin Lymphoma | CBV | 37 | 95% Confidence Interval 23 to 52 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Non-Hodgkin Lymphoma | VCp | 0 | 95% Confidence Interval 0 to 0 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Solid Tumors | VCp | 43 | 95% Confidence Interval 6 to 80 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | MM/Amyloid | Mel120 | 22 | 95% Confidence Interval 2 to 41 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | MM/Amyloid | Mel200 | 13 | 95% Confidence Interval 3 to 22 | Proportion of participants |
| Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors) | Solid Tumors | CyTtCp | 0 | 95% Confidence Interval 0 to 0 | Proportion of participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acute Leukemia | 6 | |
| Overall Study | STARTED | Hodgkin Lymphoma | 21 | |
| Overall Study | STARTED | Non-Hodgkin Lymphoma | 71 | |
| Overall Study | STARTED | MM/Amyloid | 65 | |
| Overall Study | STARTED | Solid Tumors | 11 | |
| Overall Study | COMPLETED | Acute Leukemia | 6 | |
| Overall Study | COMPLETED | Hodgkin Lymphoma | 21 | |
| Overall Study | COMPLETED | Non-Hodgkin Lymphoma | 71 | |
| Overall Study | COMPLETED | MM/Amyloid | 65 | |
| Overall Study | COMPLETED | Solid Tumors | 11 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Regimen Related Toxicity | General disorders | Acute Leukemia | 1 | 6 | 1 |
| serious | Regimen Related Toxicity | General disorders | Hodgkin Lymphoma | 9 | 21 | 9 |
| serious | Regimen Related Toxicity | General disorders | Non-Hodgkin Lymphoma | 19 | 71 | 19 |
| serious | Regimen Related Toxicity | General disorders | MM/Amyloid | 31 | 65 | 31 |
| serious | Regimen Related Toxicity | General disorders | Solid Tumors | 3 | 11 | 3 |
Source ClinicalTrials.gov
Adverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acute Leukemia | 4 | 6 |
| Total, all-cause mortality | Hodgkin Lymphoma | 8 | 21 |
| Total, all-cause mortality | Non-Hodgkin Lymphoma | 41 | 71 |
| Total, all-cause mortality | MM/Amyloid | 45 | 65 |
| Total, all-cause mortality | Solid Tumors | 6 | 11 |
| Total, other adverse events | Acute Leukemia | 0 | 6 |
| Total, other adverse events | Hodgkin Lymphoma | 0 | 21 |
| Total, other adverse events | Non-Hodgkin Lymphoma | 0 | 71 |
| Total, other adverse events | MM/Amyloid | 0 | 65 |
| Total, other adverse events | Solid Tumors | 0 | 11 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00536601
GET https://conductscience.org/api/trials/v1/NCT00536601/results?page=2