NCT00792948|Active Not RecruitingPhase 2Results

Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia

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)ClinicalTrials.gov

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5 other identifiers

NCI-2009-00800S0805CDR0000624250U10CA180888U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

157

Timeline

RegisteredNov 2008

StartedSep 2009

CompletionJan 2027

Brief 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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

8mo left

Started Sep 2009

Longer than P75 for phase_2

Geographic Reach

1 country

157 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

17.4 years study duration

Study Progress96%

Sep 2009Jan 2027

First Submitted

Initial submission to the registry

November 16, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed

10 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed

6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed

11 months until next milestone

Results Posted

Study results publicly available

April 26, 2017

Completed

9.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2027

Expected

Last Updated

April 13, 2026

Status Verified

February 1, 2026

Enrollment Period

6.8 years

First QC Date

November 16, 2008

Results QC Date

November 21, 2016

Last Update Submit

April 9, 2026

Conditions

Adult L1 Acute Lymphoblastic Leukemia Adult L2 Acute Lymphoblastic Leukemia Adult B Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Adult T Acute Lymphoblastic Leukemia Recurrent Adult Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
Will be estimated using the method of Kaplan-Meier.
12 months

Secondary Outcomes (1)

Continuous Complete Remission (CCR) Rate
18 months

Other Outcomes (2)

Overall Survival (OS)
From the date of initial registration on the study until death from any cause, assessed up to 5 years
MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry
Up to 5 years

Study Arms (1)

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

CyclophosphamideDRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719