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Alkylating agents

Chemotherapy + Stem Cell Transplant for Acute Lymphoblastic Leukemia

Phase 2
Waitlist Available
Led By Farhad Ravandi-Kashani
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have a morphologic diagnosis of acute lymphoblastic leukemia (ALL) with evidence of ALL involvement in bone marrow and/or blood
Patients must be Philadelphia (Ph) positive and/or BCR/ABL positive
Must not have
Patients with L3 (Burkitts)
Patients with M0 acute myeloid leukemia (AML) or mixed lineage leukemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying side effects and efficacy of combine chemo w/ or w/o donor stem cell transplant for treating patients w/ acute lymphoblastic leukemia.

Who is the study for?
This trial is for patients with acute lymphoblastic leukemia who have not had more than one prior treatment, are not HIV positive, and do not have significant heart disease or other serious health issues. They must be Philadelphia chromosome or BCR/ABL positive and cannot be pregnant. A matched stem cell donor must be available.
What is being tested?
The study tests if combination chemotherapy with or without a donor stem cell transplant can effectively treat acute lymphoblastic leukemia. It examines how well multiple drugs work together to stop cancer growth and whether a transplant can help the immune system fight cancer cells.
What are the potential side effects?
Side effects may include damage to organs from chemotherapy drugs, increased risk of infection post-transplant, potential graft-versus-host disease where the donated cells attack the body, fatigue, nausea, hair loss, mouth sores, and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with acute lymphoblastic leukemia affecting my bone marrow or blood.
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My leukemia is Philadelphia chromosome positive.
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I do not have any major heart diseases.
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I achieved complete remission after up to 2 rounds of initial chemotherapy.
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My side effects from previous treatments are mild.
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I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with Burkitt's lymphoma.
Select...
I have acute myeloid leukemia without spread beyond the bone marrow.
Select...
I have had treatment after remission or my leukemia has returned after being in remission.
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My cancer is growing quickly.
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I have fluid buildup in my heart, abdomen, or lungs not caused by leukemia.
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I have received a stem cell transplant from a donor.
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I have a serious heart condition.
Select...
I don't have a perfectly matched donor for a transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
Secondary study objectives
Continuous Complete Remission (CCR) Rate
Other study objectives
MRD as Assessed Using Real-time Quantitative Polymerase Chain Reaction and Flow Cytometry
Overall Survival (OS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, transplant, maintenance)Experimental Treatment18 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Dasatinib
2012
Completed Phase 3
~2320
Vincristine Sulfate
2005
Completed Phase 3
~10270
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Etoposide
2010
Completed Phase 3
~2960
Sirolimus
2013
Completed Phase 4
~2750
Leucovorin Calcium
2011
Completed Phase 3
~12500
Cytarabine
2016
Completed Phase 3
~3330
Prednisone
2014
Completed Phase 4
~2500
Cyclophosphamide
2010
Completed Phase 4
~2310
Methotrexate
2019
Completed Phase 4
~4400
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Tacrolimus
2019
Completed Phase 4
~5510
Methylprednisolone
2015
Completed Phase 4
~2280
Filgrastim
2000
Completed Phase 3
~3690
Total-Body Irradiation
1997
Completed Phase 3
~1180
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,091 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorSWOG Cancer Research Network
8 Previous Clinical Trials
669 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00792948 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Treatment (chemotherapy, transplant, maintenance)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00792948 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00792948 — Phase 2
~6 spots leftby Dec 2025
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