Combination chemotherapy for relapsed or refractory acute lymphoblastic leukemia and related conditions
Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
This study is testing a new combination of chemotherapy drugs to see if it can help people with relapsed or hard-to-treat acute lymphoblastic leukemia and related blood cancers feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, ofatumumab, rituximab |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03136146 on ClinicalTrials.gov |
What this trial studies
This phase II trial evaluates the effectiveness and safety of a combination chemotherapy regimen in patients with relapsed or refractory acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia. The treatment involves multiple drugs, including clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib, administered over a specified schedule. The primary goal is to assess the overall response rate and collect data on safety and toxicity, while secondary objectives include evaluating the duration of complete response, event-free survival, and overall survival.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 15 years and older with relapsed or refractory acute lymphoblastic leukemia or related lymphomas.
Not a fit: Patients with conditions not related to acute lymphoblastic leukemia or those who have not met the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with difficult-to-treat forms of leukemia and lymphoma.
How similar studies have performed: Other studies have shown promise with similar combination chemotherapy approaches in treating relapsed or refractory leukemias and lymphomas.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Maro Ohanian — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.