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

ConditionsRecurrent Acute Lymphoblastic LeukemiaRecurrent Adult Lymphoblastic LymphomaRecurrent Burkitt LeukemiaRecurrent Burkitt LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory Acute Lymphoblastic LeukemiaRefractory Burkitt LeukemiaRefractory Burkitt LymphomaRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory Lymphoblastic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorM.D. Anderson Cancer Center

About this trial

This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Active >= grade 3 peripheral neuropathy

Active hepatic graft-versus-host disease

Known positivity for hepatitis B or C

Pregnancy

Trial design

Design model

Single group

Treatments tested in this trial

  • Bortezomib

    Drug

    Given SC

  • Clofarabine

    Drug

    Given IV

  • Cyclophosphamide

    Drug

    Given IV

  • Dexamethasone

    Drug

    Given IV or PO

  • Etoposide

    Drug

    Given IV

  • Ofatumumab

    Biological/Vaccine

    Given IV

  • Pegfilgrastim

    Biological/Vaccine

    Given SC

  • Rituximab

    Biological/Vaccine

    Given IV

  • Vincristine Sulfate Liposome

    Drug

    Given IV

Treatment groups

42 Participants
are divided into 1 treatment group
Group A: Treatment (combination chemotherapy)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events.

Time frame
Up to 8 years
2

Overall response rate (ORR) (Phase II)

Will be estimated along with the exact 95% confidence interval.

Time frame
Up to 8 years

Secondary outcomes

1

Overall survival

Will be estimated using the method of Kaplan and Meier. The log-rank tests will be used to compare the time-to-event outcomes among subgroups of patients.

Time frame
From initiation of treatment, assessed up to 8 years
2

Event free survival

Will be estimated using the method of Kaplan and Meier. The log-rank tests will be used to compare the time-to-event outcomes among subgroups of patients.

Time frame
From the treatment start, assessed up to 8 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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