Trial · NCT00036738
Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib
NCT00036738, Phase 2, Completed, Fred Hutchinson Cancer Center; results first posted 2017-08-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib. Trials, record NCT00036738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00036738
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib
- NCT number
- NCT00036738
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Fred Hutchinson Cancer Center
- Conditions
Adult Acute Lymphoblastic Leukemia in Remission, Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Blastic Phase, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Chronic Phase of Disease, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Disease
- Interventions
Cyclosporine, Dasatinib, Fludarabine Phosphate, Imatinib Mesylate, Mycophenolate Mofetil, Nilotinib, Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation, Therapeutic Allogeneic Lymphocytes, Total-Body Irradiation
- First posted
- 2003-01-27
- Last updated
- 2020-01-29
- Results first posted
- 2017-08-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Relapse Free Survival | Assessed up to 1 year | Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of \> 5% blasts after a documented complete remission. |
| Secondary | Leukemia-free Survival | Assessed up to 5 years | Number of patients surviving in CR up to five years post-transplant. |
| Secondary | Overall Survival | Assessed up to 5 years | Number of patients surviving up to five years post-transplant. |
| Secondary | Transplant-related Mortality | At day 100 | Number of patients with TRM within 100 days post-transplant. |
| Secondary | Transplant-related Mortality | At 1 year | Number of patients with TRM within one year post-transplant. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Relapse Free Survival | Assessed up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Leukemia-free Survival | Assessed up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival | Assessed up to 5 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Transplant-related Mortality | At day 100 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Transplant-related Mortality | At 1 year | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Relapse Free Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 3 | Participants | ||
| Leukemia-free Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 6 Months | 19 | Participants | |
| Leukemia-free Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 Year | 17 | Participants | |
| Leukemia-free Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 2 Years | 13 | Participants | |
| Leukemia-free Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 3 Years | 11 | Participants | |
| Leukemia-free Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 4 Years | 11 | Participants | |
| Leukemia-free Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 5 Years | 10 | Participants | |
| Overall Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 6 Months | 26 | Participants | |
| Overall Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 Year | 24 | Participants | |
| Overall Survival | Treatment (Allogeneic Nonmyeloablative HSCT) | 2 Years | 19 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Allogeneic Nonmyeloablative HSCT) | 28 | |
| Overall Study | COMPLETED | Treatment (Allogeneic Nonmyeloablative HSCT) | 28 | |
| Overall Study | NOT COMPLETED | Treatment (Allogeneic Nonmyeloablative HSCT) | 0 |
Source ClinicalTrials.gov
Adverse events11
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 |
|---|---|---|---|---|---|---|
| other | Anaphylaxis | Immune system disorders | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
| other | Atrial flutter | Cardiac disorders | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
| other | Blood bilirubin increased | Investigations | Treatment (Allogeneic Nonmyeloablative HSCT) | 3 | 28 | 3 |
| other | Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
| other | Pneumonitis | Respiratory, thoracic and mediastinal disorders | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
| other | Transient ischemic attacks | Nervous system disorders | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
| serious | Blood bilirubin increased | Investigations | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
| serious | Encephalopathy | Nervous system disorders | Treatment (Allogeneic Nonmyeloablative HSCT) | 1 | 28 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Allogeneic Nonmyeloablative HSCT) | ||
| Total, other adverse events | Treatment (Allogeneic Nonmyeloablative HSCT) | 8 | 28 |
| Total, serious adverse events | Treatment (Allogeneic Nonmyeloablative HSCT) | 2 | 28 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| P01CA078902 | Preventing Relapse After Non-myeloablative Stem Cell Transplantation: The Final Challenge | SANDMAIER, BRENDA MARIE; WALTER, ROLAND BRUNO | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1999 to 2025 | NIH RePORTER |
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 | 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/NCT00036738
GET https://conductscience.org/api/trials/v1/NCT00036738/registered