Carfilzomib and Hyper-CVAD in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoma

Conditions

• Contiguous Stage II Adult Lymphoblastic Lymphoma
• Noncontiguous Stage II Adult Lymphoblastic Lymphoma
• Stage I Adult Lymphoblastic Lymphoma
• Stage III Adult Lymphoblastic Lymphoma
• Stage IV Adult Lymphoblastic Lymphoma
• Untreated Adult Acute Lymphoblastic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 64 Years

Healthy Volunteers

Not accepted

Interventions

• carfilzomib — DRUG
  Given IV
• cyclophosphamide — DRUG
  Given IV
• vincristine sulfate — DRUG
  Given IV
• doxorubicin hydrochloride — DRUG
  Given IV
• dexamethasone — DRUG
  Given PO
• methotrexate — DRUG
  Given IV
• cytarabine — DRUG
  Given IV
• leucovorin calcium — DRUG
  Given IV or PO
• methylprednisolone — DRUG
  Given IV
• rituximab — BIOLOGICAL
• laboratory biomarker analysis — OTHER
  Correlative studies

Study Details

This phase I trial studies the side effects and best dose of carfilzomib when given together with the hyperfractionated (hyper)-cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone (CVAD) chemotherapy regimen in treating patients with newly diagnosed acute lymphoblastic leukemia or lymphoma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carfilzomib with combination chemotherapy may kill more cancer cells.

Key Dates

Start date

Dec 17, 2015

Status verified

Mar 2022

Primary completion

Dec 13, 2017

Completion

Jan 11, 2018

Study Design

Enrollment

10 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (carfilzomib and hyper-CVAD)
  Patients receive carfilzomib IV over 30 minutes on days 0, 1, 7, and 8. Patients also receive hyper-CVAD comprising cyclophosphamide IV over 2 hours every 12 hours for 6 doses beginning on day 1, vincristine sulfate IV on days 4 and 11, doxorubicin hydrochloride IV over 2-24 hours on day 4, and dexamethasone PO on days 1-4 and 11-14 (courses 1 and 3) and methotrexate IV over 24 hours on day 1, cytarabine IV over 2 hours every 12 hours for 4 doses starting on day 2, leucovorin calcium IV or PO every 6 hours beginning 36 hours after the start of methotrexate infusion, and methylprednisolone IV every 12 hours for 6 doses beginning on day 1 (courses 2 and 4). Patients with CD20 positive disease also receive rituximab twice daily on days 1 and 11 of courses 1 and 3 and days 1 and 8 of courses 2 and 4. Treatment repeats every 3-4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum tolerated dose of carfilzomib with hyper-CVAD, defined as the dose that produces dose limiting toxicity in 17% or fewer (1/6) of patients, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4 [ Time Frame: Up to 56 days (after second course) ]

Locations (1)

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