Chemotherapy + Stem Cell Transplant for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

+173 other locations

Overseen by Farhad Ravandi-Kashani

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Farhad Ravandi-Kashani

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

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.

Inclusion Criteria

Patients must have immunophenotyping of the blood or marrow lymphoblasts to determine lineage

Patients must meet specific laboratory criteria for bilirubin, liver enzymes, and kidney function

I have been diagnosed with acute lymphoblastic leukemia affecting my bone marrow or blood.

Exclusion Criteria

I have received a stem cell transplant from a donor.

I have been diagnosed with Burkitt's lymphoma.

I have acute myeloid leukemia without spread beyond the bone marrow.

Treatment Details

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation (Procedure)
• Cyclophosphamide (Alkylating agents)
• Dexamethasone (Corticosteroid)
• Doxorubicin Hydrochloride (Anti-tumor antibiotic)
• Laboratory Biomarker Analysis (Other)
• Methotrexate (Anti-metabolites)
• Methylprednisolone (Corticosteroid)
• Peripheral Blood Stem Cell Transplantation (Procedure)
• Prednisone (Corticosteroid)
• Total-Body Irradiation (Radiation)
• Vincristine Sulfate (Vinca alkaloids)

Trial Overview 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.

Participant Groups

Group I: Treatment (chemotherapy, transplant, maintenance) Experimental Treatment 18 Interventions

See Detailed Description

Cyclophosphamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School