CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 97 enrolled / 97 target
Drug / intervention
Cyclophosphamide +17 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00792948
NCT00792948Phase 2ActiveUpdate Overdue (0.5/mo)Completion was 120mo ago

Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study)

National Cancer Institute (NCI)·interventional·Posted Nov 18, 2008·Updated Jun 17, 2026

In Brief

A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Cyclophosphamide, and 16 other interventions for Acute Lymphoblastic Leukemia and 6 related conditions. Active but no longer recruiting, targeting 97 participants across 157 sites.

Signals

Enrollment appears stalled

Detailed Summary

This phase II trial is studying the side effects of giving combination chemotherapy together with or without donor stem cell transplant and to see how well it works in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect).

Study Details

Timeline

Phase 2Active
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 18, 2008
Enrollment StartSep 1, 2009
Primary CompletionJun 1, 2016
Study CompletionJan 6, 2027
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 17.6 years ago

Arms & Interventions

Treatment (chemotherapy, transplant, maintenance)experimental

See Detailed Description

Procedure: Allogeneic Hematopoietic Stem Cell TransplantationDrug: CyclophosphamideDrug: CytarabineDrug: DasatinibDrug: DexamethasoneDrug: Doxorubicin HydrochlorideDrug: EtoposideBiological: FilgrastimOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MethotrexateDrug: MethylprednisoloneProcedure: Peripheral Blood Stem Cell TransplantationDrug: PrednisoneDrug: SirolimusDrug: TacrolimusRadiation: Total-Body IrradiationDrug: Vincristine Sulfate

Interventions

Allogeneic Hematopoietic Stem Cell Transplantationprocedure

Undergo allogeneic stem cell transplant

Cyclophosphamidedrug

Given IV

Cytarabinedrug

Given IT

Dasatinibdrug

Given PO

Dexamethasonedrug

Given IV or PO

Doxorubicin Hydrochloridedrug

Given IV

Etoposidedrug

Given IV

Filgrastimbiological

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Leucovorin Calciumdrug

Given IV

Methotrexatedrug

Given IV or IT

Methylprednisolonedrug

Given IV

Peripheral Blood Stem Cell Transplantationprocedure

Undergo allogeneic stem cell transplant

Prednisonedrug

Given PO

Sirolimusdrug

Given PO

Tacrolimusdrug

Given IV

Total-Body Irradiationradiation

Undergo TBI

Vincristine Sulfatedrug

Given IV