Venetoclax + Chemotherapy for Acute Lymphoblastic Leukemia

Recruiting in Palo Alto (17 mi)

Elias Jabbour | MD Anderson Cancer Center

Overseen byElias Jabbour, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of venetoclax and how well it works in combination with low-intensity chemotherapy in patients with B- or T-cell acute lymphoblastic leukemia that has not responded to treatment or that has come back. Venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, including vincristine, cyclophosphamide, dexamethasone, rituximab, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with low-intensity chemotherapy may work better in treating patient with B- or T-cell acute lymphoblastic leukemia.

Eligibility Criteria

This trial is for adults with B- or T-cell acute lymphoblastic leukemia that's come back or didn't respond to treatment. They must have acceptable liver and kidney function, not be pregnant, agree to use birth control, and can't have HIV, hepatitis B/C, a weak heart, prior venetoclax treatment, other serious cancers or bleeding disorders.

Inclusion Criteria

Aspartate aminotransferase (AST) =< 3 x ULN, unless due to disease involvement of the liver or hemolysis, in which case an AST =< 10 x ULN is acceptable

Alanine aminotransferase (ALT) =< 3 x ULN, unless due to disease involvement of the liver or hemolysis, in which case an ALT =< 10 x ULN is acceptable

I am a woman who can have children and have a recent negative pregnancy test.

+6 more

Exclusion Criteria

I have a serious infection that isn't getting better with antibiotics.

I have leukemia that is either Philadelphia chromosome-positive ALL or Burkitt.

I have not taken strong medication that affects liver enzymes within the last week.

+9 more

Participant Groups

The study tests the effectiveness of a drug called Venetoclax combined with low-intensity chemotherapy (including drugs like vincristine and methotrexate) on patients with relapsed/refractory acute lymphoblastic leukemia. It aims to find the best dose while assessing how well it stops tumor growth.

1Treatment groups

Experimental Treatment

Group I: Experimental (venetoclax, vincristine, cyclophosphamide)Experimental Treatment10 Interventions

See Detailed Description.