Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04933617
Phase
PHASE1
Status
Terminated

Conditions

  • Burkitt Lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Germinal Center B-cell Type (GCB)
  • High-grade B-cell Lymphoma
  • T-cell/Histocyte-rich Large B-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — BIOLOGICAL
    Rituximab 375 mg/m\^2 intravenous (IV) per protocol on Day 1 of each cycle up to 6 cycles
  • Etoposide — DRUG
    Etoposide 50 mg/m\^2/day continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles
  • Copanlisib — BIOLOGICAL
    Copanlisib intravenous (IV) is administered at a fixed dose (30 mg, 45 mg, or 60 mg) on days 1 and 5 of each 21-day cycle for up to 6 cycles
  • Cyclophosphamide — DRUG
    Cyclophosphamide 750 mg/m\^2 intravenous (IV) on Day 5 of each cycle up to 6 cycles
  • Doxorubicin — DRUG
    Doxorubicin 10 mg/m\^2/day continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles
  • Vincristine — DRUG
    Vincristine 0.4 mg/m\^2/day (no cap) continuous intravenous infusion (CIVI) on Days 1-4 of each cycle up to 6 cycles
  • Prednisone — DRUG
    Prednisone 60 mg/m\^2 by mouth (PO) twice a day (BID) Days 1-5 (total 120mg/m\^2/day)
  • ECHO — DIAGNOSTIC_TEST
    At screening.
  • EKG — DIAGNOSTIC_TEST
    At screening.
  • MRI Brain — DIAGNOSTIC_TEST
    At screening.
  • 18F-FDG - PET — DIAGNOSTIC_TEST
    At screening, baseline, after cycle 1, 3, and 6, and end of treatment.
  • CT Scan — DIAGNOSTIC_TEST
    At screening, baseline, after cycle 1, 3, and 6, end of treatment and follow-up.
  • Bone Marrow Aspiration — PROCEDURE
    At screening and end of treatment.
  • Bone Marrow Biopsy — PROCEDURE
    At screening and end of treatment.
  • Lumbar Puncture (LP) — DIAGNOSTIC_TEST
    Baseline and end of treatment.

Study Details

Background: Burkitt Lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL) are aggressive B cell lymphomas. Frontline treatment does not always work. Researchers want to see if a combination of drugs can help. Objective: To learn if it is safe to give people with certain cancers copanlisib together with rituximab and combination chemotherapy dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R). Eligibility: People ages 18 and older with relapsed and/or refractory highly aggressive B-cell lymphomas such as BL and certain types of diffuse large B-cell lymphoma (DLBCL). Design: Participants will be screened with: Medical history Physical exam Bone marrow aspiration and biopsy. A needle will be put into their hipbone. Marrow will be removed. Imaging scans of the chest, abdomen, pelvis, and/or brain Tumor biopsy (if needed) Blood and urine tests Heart function tests Treatment will be given in 21-day cycles for up to 6 cycles. Participants will get copanlisib by intravenous (IV) infusion. They will also get a group of medicines called DA-EPOCH-R, as follows. They will get rituximab by IV infusion. Doxorubicin, etoposide, and vincristine will be mixed together in an IV bag and given by continuous IV infusion over 4 days. They will get cyclophosphamide by IV infusion. They will take prednisone by mouth. Participants will have frequent study visits. At these visits, they will repeat some screening tests. They may give tissue, saliva, and cheek swab samples. They will have at least one spinal tap. For this, a needle will be inserted into the spinal canal. Fluid will be removed. Participants will have a visit 30 days after treatment ends. They will have follow-up visits for at least 5 years.

Key Dates

Start date
Mar 24, 2022
Status verified
Jun 2024
Primary completion
Nov 30, 2023
Completion
Nov 30, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1- Dose Escalation, Original Copanlisib Intravenous (IV)
    Copanlisib intravenous (IV) per dose level (30 mg, 45 mg, or 60 mg) on day 1 of each 21-day cycle in combination with standard dosing dose adjusted rituximab, etoposide, prednisolone, vincristine, cyclophosphamide, doxorubicin (DA-EPOCH-R) to determine recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of copanlisib. Up to 6 cycles total.
  • Experimental: Arm 2 - Dose Expansion, Modified Copanlisib Intravenous (IV)
    Copanlisib intravenous (IV) at the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD) on day 1 of each 21-day cycle in combination with standard dosing dose adjusted rituximab, etoposide, prednisolone, vincristine, cyclophosphamide, doxorubicin (DA-EPOCH-R). Up to 6 cycles total.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) [ Time Frame: 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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