Trial · NCT00634244
Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
NCT00634244, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2015-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia. Trials, record NCT00634244. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00634244
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparing Three Different Combination Chemotherapy Regimens in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
- NCT number
- NCT00634244
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 92 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Recurrent Adult Acute Myeloid Leukemia
- Interventions
- alvocidib, mitoxantrone hydrochloride, carboplatin, cytarabine, sirolimus, etoposide, topotecan hydrochloride
- First posted
- 2008-03-12
- Last updated
- 2015-07-07
- Results first posted
- 2015-07-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Rate of Complete Remission (CR+CRi) | Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration. | CR requires: 1. peripheral blood counts: neutrophil count ≥ 1.0 x 10\^9/L, platelet count ≥ 100 x 10\^9/L, reduced hemoglobin concentration or hematocrit has no bearing on remission status, and leukemic blasts must not be present in the peripheral blood. 2. bone marrow aspirate and biopsy: maturation of all cell lines must be present, ≤ 5% blasts, auer rods must not be detectable. 3. extramedullary leukemia, such as central nervous system (CNS) or soft tissue involvement, must not be present. CRi requires that all criteria for complete remission be satisfied except patients can have residual neutropenia (\<1 x 10\^9/L) or thrombocytopenia (\<100 x 10\^9/L). |
| Secondary | The Rate of Treatment Failure | Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration. | The definition of treatment failure will include: * ≥ 5% leukemic blasts at the time of pre-consolidation marrow * Death during/following induction chemotherapy (pre-consolidation) * Persisting marrow hypoplasia and pancytopenia for ≥ 2 months after chemotherapy * CNS or extramedullary disease at the time of pre-consolidation * Leukemia persistence after completion of induction treatment. Leukemia persistence is defined as greater than 10% residual blasts on marrow biopsy done 5-7 days after completion of induction chemotherapy |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Rate of Complete Remission (CR+CRi) | Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration. | Eligible and treated | proportion of participants | NUMBER |
| SECONDARY | The Rate of Treatment Failure | Assessed every 3 months for the first 2 years and then every 6 months until relapse or death up to 3 years from registration. | Eligible and treated | proportion of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Rate of Complete Remission (CR+CRi) | Arm A (Carboplatin+Topotecan Hydrochloride) | 0.143 | 90% Confidence Interval 0.071 to 0.347 | proportion of participants | |
| The Rate of Complete Remission (CR+CRi) | Arm B (Alvocidib+Cytarabine+Mitoxantrone) | 0.278 | 90% Confidence Interval 0.161 to 0.43 | proportion of participants | |
| The Rate of Complete Remission (CR+CRi) | Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) | 0.15 | 90% Confidence Interval 0.042 to 0.344 | proportion of participants | |
| The Rate of Treatment Failure | Arm A (Carboplatin+Topotecan Hydrochloride) | 0.86 | 90% Confidence Interval 0.72 to 0.94 | proportion of participants | |
| The Rate of Treatment Failure | Arm B (Alvocidib+Cytarabine+Mitoxantrone) | 0.72 | 90% Confidence Interval 0.57 to 0.84 | proportion of participants | |
| The Rate of Treatment Failure | Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) | 0.84 | 90% Confidence Interval 0.64 to 0.96 | proportion of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A (Carboplatin and Topotecan Hydrochloride) | 35 | |
| Overall Study | STARTED | Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine) | 37 | |
| Overall Study | STARTED | Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus) | 20 | |
| Overall Study | Eligible and Treated | Arm A (Carboplatin and Topotecan Hydrochloride) | 35 | |
| Overall Study | Eligible and Treated | Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine) | 36 | |
| Overall Study | Eligible and Treated | Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus) | 20 | |
| Overall Study | COMPLETED | Arm A (Carboplatin and Topotecan Hydrochloride) | 34 | |
| Overall Study | COMPLETED | Arm B (Alvocidib, Mitoxantrone Hydrochloride, Cytarabine) | 24 | |
| Overall Study | COMPLETED | Arm C (Mitoxantrone Hydrochloride, Cytarabine, Sirolimus) | 20 | |
| Overall Study | NOT COMPLETED | Arm A (Carboplatin and Topotecan Hydrochloride) | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events447
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 | Anemia | Blood and lymphatic system disorders | Arm A (Carboplatin+Topotecan Hydrochloride) | 34 | 35 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B (Alvocidib+Cytarabine+Mitoxantrone) | 32 | 36 | |
| other | Anemia | Blood and lymphatic system disorders | Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) | 20 | 20 | |
| other | Sinus tachycardia | Cardiac disorders | Arm A (Carboplatin+Topotecan Hydrochloride) | 0 | 35 | |
| other | Sinus tachycardia | Cardiac disorders | Arm B (Alvocidib+Cytarabine+Mitoxantrone) | 4 | 36 | |
| other | Sinus tachycardia | Cardiac disorders | Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) | 2 | 20 | |
| other | Chills | General disorders | Arm A (Carboplatin+Topotecan Hydrochloride) | 1 | 35 | |
| other | Chills | General disorders | Arm B (Alvocidib+Cytarabine+Mitoxantrone) | 10 | 36 | |
| other | Chills | General disorders | Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) | 4 | 20 | |
| other | Edema limbs | General disorders | Arm A (Carboplatin+Topotecan Hydrochloride) | 5 | 35 |
1 to 10 of 447Source ClinicalTrials.gov
See all 447 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Carboplatin+Topotecan Hydrochloride) | ||
| Total, all-cause mortality | Arm B (Alvocidib+Cytarabine+Mitoxantrone) | ||
| Total, all-cause mortality | Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) | ||
| Total, other adverse events | Arm A (Carboplatin+Topotecan Hydrochloride) | 35 | 35 |
| Total, other adverse events | Arm B (Alvocidib+Cytarabine+Mitoxantrone) | 36 | 36 |
| Total, other adverse events | Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) | 20 | 20 |
| Total, serious adverse events | Arm A (Carboplatin+Topotecan Hydrochloride) | 35 | 35 |
| Total, serious adverse events | Arm B (Alvocidib+Cytarabine+Mitoxantrone) | 36 | 36 |
| Total, serious adverse events | Arm C (Sirolimus+Mitoxantrone+Etoposide+Cytarabine) | 20 | 20 |
Source ClinicalTrials.gov
Papers0
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 |
|---|---|---|---|---|---|
| U10CA021115 | Eastern Cooperative Oncology Group Operations Office | COMIS, ROBERT L | FRONTIER SCI & TECHNOLOGY RSCH FDN, INC | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
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/NCT00634244
GET https://conductscience.org/api/trials/v1/NCT00634244/events?page=2