Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia

Launched by M.D. ANDERSON CANCER CENTER · Apr 27, 2017

Keywords

ClinConnect Summary

This clinical trial is studying a combination of chemotherapy drugs to see how well they work for patients with certain types of blood cancers, including acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, and Burkitt lymphoma or leukemia that have either returned after treatment or did not respond to previous therapies. The trial will test different chemotherapy drugs, like clofarabine and vincristine, which can help stop cancer cells from growing or spreading.

To be eligible for the trial, participants need to be over 15 years old and have a specific type of relapsed or refractory (not responding to treatment) leukemia or lymphoma. They should also meet certain health criteria, like having stable liver and kidney function. Participants can expect to receive a combination of these chemotherapy drugs and will be monitored closely for side effects. The trial is currently recruiting, which means they are looking for patients to join the study. If you or someone you know is interested, it's important to discuss this option with a healthcare provider to see if it might be a good fit.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):
• • Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)
• • Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or "double-hit" leukemia/lymphoma (phase II only)
• • At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset
• • Age older than 15 years
• • Eastern Cooperative Oncology Group (ECOG) performance status =\< 3 (There may be certain patients with performance status \[PS\] 3 in the context of rapidly proliferative/refractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)
• • Serum bilirubin =\< 1.5 mg/dL
• • Serum glutamate pyruvate transaminase (SGPT) =\< 3 x upper limit normal (ULN), with exception for Gilbert's syndrome
• • Estimated creatinine clearance or GFR (glomerular filtration rate) \>= 50 mL/min
• • Signed informed consent
• Exclusion Criteria:
• • Active \>= grade 3 peripheral neuropathy
• • Active hepatic graft-versus-host disease
• • Known positivity for hepatitis B or C
• • Pregnancy
• • Breast feeding