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NCT01256398 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
66
Enrollment target

NCT01256398: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01256398 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01256398, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
66 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Cytarabine
  • PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
  • PROCEDURE Autologous Hematopoietic Stem Cell Transplantation
  • BIOLOGICAL Alemtuzumab

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2010-12-14
Est. Completion 2021-11-15
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01256398 record still lists

NCT01256398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01256398 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01256398 about?

NCT01256398 is a clinical study titled "Dasatinib Followed by Stem Cell Transplant in Treating Older Patients With Newly Diagnosed Acute Lymphoblastic Leukemia". 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 befor...

What is the current status of trial NCT01256398?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2010-12-14. Estimated completion is 2021-11-15.

What interventions are being tested in trial NCT01256398?

The interventions under investigation include: Cyclophosphamide (DRUG), Cytarabine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Autologous Hematopoietic Stem Cell Transplantation (PROCEDURE), Alemtuzumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01256398?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01256398's enrollment target sits among peer trials

66 975th of 2000 higher than 1,014 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01256398, the US trial registry maintained by the National Library of Medicine. NCT01256398 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.