Chemotherapy + Stem Cell Transplant for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

+172 other locations

Overseen ByFarhad 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).

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

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

My leukemia is Philadelphia chromosome positive.

I do not have any major heart diseases.

I achieved complete remission after up to 2 rounds of initial chemotherapy.

My side effects from previous treatments are mild.

I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

I have been diagnosed with Burkitt's lymphoma.

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

I have had treatment after remission or my leukemia has returned after being in remission.

My cancer is growing quickly.

I have fluid buildup in my heart, abdomen, or lungs not caused by leukemia.

I have received a stem cell transplant from a donor.

I have a serious heart condition.

I don't have a perfectly matched donor for a transplant.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, transplant, maintenance)Experimental Treatment18 Interventions

See Detailed Description

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Cytoxan for: