Combination chemotherapy for relapsed or refractory acute lymphoblastic leukemia and related conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• M D Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Maro Ohanian — M.D. Anderson Cancer Center

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fecal transplant to restore gut microbiome before CAR T therapy for relapsed or refractory B‑cell lymphoma

  This trial will test whether a fecal microbiome transplant can restore healthy gut bacteria and improve outcomes for adults with relapsed or refractory CD19 B‑cell lymphoma who received high‑risk antibiotics and are receiving CAR T‑cell therapy.

  Recruiting Phase 2 City of Hope Medical Center · Duarte, California · NCT07042438

• ViPOR combination therapy for relapsed or refractory aggressive B‑cell lymphoma

  This treatment will try a five‑drug targeted combination called ViPOR (venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide) in adults whose aggressive B‑cell lymphoma has relapsed or not responded to prior therapy, focusing on specific genetic subtypes like CD10‑negative DLBCL and high‑grade B‑cell lympho

  Recruiting at 99 sites Phase 2 National Cancer Institute (NCI) · Tucson, Arizona and 114 other locations · NCT06649812

• Combination treatment of epcoritamab and ibrutinib for aggressive B-cell lymphoma

  This study is testing a new combination of two treatments, epcoritamab and ibrutinib, to see if they can help people with aggressive B-cell lymphoma that hasn't responded to other therapies.

  Recruiting at 3 sites Phase 1/2 Ohio State University Comprehensive Cancer Center · Minneapolis, Minnesota and 2 other locations · NCT06536049

• Tegavivint treatment for patients with relapsed or refractory large B-cell lymphoma

  This study is testing a new treatment called tegavivint to see if it can help people with relapsed or refractory large B-cell lymphoma feel better and how much of the drug is safe to use.

  Recruiting Phase 1 Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT05755087

• Genetically engineered CAR T-cells for treating certain blood cancers

  This study is testing a new type of treatment using specially modified immune cells to see if they can help people with certain blood cancers that haven't responded to other treatments.

  Recruiting at 2 sites Phase 1 Ohio State University Comprehensive Cancer Center · Columbus, Ohio and 1 other locations · NCT05418088

• Using a radioactive antibody followed by stem cell transplant to treat high-risk leukemia or myelodysplastic syndrome

  This study is testing a new radioactive treatment combined with a stem cell transplant to see if it can help people with high-risk leukemia or myelodysplastic syndrome feel better and improve their chances of recovery.

  Recruiting Phase 1/2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT03670966

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.