NCT01256398|CompletedPhase 2ResultsDMC

Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG

National Cancer Institute (NCI)ClinicalTrials.gov

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6 other identifiers

NCI-2011-02621CALGB 10701/CTSU C10701CDR0000690286CALGB-10701U10CA180821U10CA031946

Study Type

interventional

Target

Locations

1 country

Sites

101

Timeline

RegisteredDec 2010

StartedDec 2010

CompletionNov 2021

Brief Summary

This phase II clinical trial studies how well dasatinib followed by stem cell transplant works in treating older patients with newly diagnosed acute lymphoblastic leukemia. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy before a stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. Monoclonal antibodies, such as alemtuzumab, may interfere with the ability of cancer cells to grow and spread. Giving more than one drug (combination chemotherapy) and giving dasatinib together with chemotherapy may kill more cancer cells.

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

Completed

Started Dec 2010

Longer than P75 for phase_2

Geographic Reach

1 country

101 active sites

Status

completed

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

10.9 years study duration

First Submitted

Initial submission to the registry

December 7, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2010

Completed

6 days until next milestone

Study Start

First participant enrolled

December 14, 2010

Completed

6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed

1.5 years until next milestone

Results Posted

Study results publicly available

May 21, 2019

Completed

2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed

Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

6.9 years

First QC Date

December 7, 2010

Results QC Date

February 4, 2019

Last Update Submit

March 7, 2023

Conditions

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

Outcome Measures

Primary Outcomes (1)

Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause
Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05.
At 3 years after CR

Secondary Outcomes (5)

Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)
10 years
Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.
10 years
Overall Survival (OS)
10 years
Disease Free Survival (DFS)
10 years
Response
10 years

Study Arms (1)

Treatment (chemotherapy, transplant)

EXPERIMENTAL

See Detailed Description

Biological: AlemtuzumabProcedure: Allogeneic Hematopoietic Stem Cell TransplantationProcedure: Autologous Hematopoietic Stem Cell TransplantationDrug: CyclophosphamideDrug: CytarabineDrug: DasatinibDrug: Daunorubicin HydrochlorideDrug: DexamethasoneDrug: Etoposide PhosphateBiological: FilgrastimDrug: Fludarabine PhosphateProcedure: In Vitro-Treated Peripheral Blood Stem Cell TransplantationOther: Laboratory Biomarker AnalysisDrug: Leucovorin CalciumDrug: MelphalanDrug: MercaptopurineDrug: MethotrexateBiological: PegfilgrastimOther: Pharmacological StudyDrug: TacrolimusDrug: Vincristine Sulfate

Interventions

AlemtuzumabBIOLOGICAL

Given IV

Also known as: Anti-CD52 Monoclonal Antibody, Campath, Campath-1H, LDP-03, Lemtrada, MabCampath, Monoclonal Antibody Campath-1H