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Completed
NCT03259503
Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant
Conditions: Recurrent Diffuse Large B-Cell Lymphoma, Recurrent T-Cell Non-Hodgkin Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Refractory Hodgkin Lymphoma, Refractory T-Cell Non-Hodgkin Lymphoma
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 50
Sponsor: M.D. Anderson Cancer Center
Location: M D Anderson Cancer Center Houston Texas
Summary
This phase I trial studies the side effects and best dose of olaparib when given together with high-dose chemotherapy in treating patients with lymphomas that have come back or does not treatment and are undergoing stem cell transplant. Drugs used in chemotherapy, such as olaparib, vorinostat, gemcitabine, busulfan, and melphalan, 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. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and high-dose chemotherapy together may work better in treating patients with relapsed/refractory lymphomas undergoing stem cell transplant than with chemotherapy alone.
Eligibility Criteria
Inclusion Criteria:
1. Age 18-65
2. Patients with:
2.1 Diffuse large B-cell lymphoma (DLBCL) with one of the following: 2.1.1 Primary refractory (no CR to 1st line) 2.1.2 High-risk relapse, defined as any of the following: CR1 \1, or LDH \> 225 U/L. 2.1.3 Refractory relapse: No response to \>/= 1 salvage line and not eligible to receive other novel salvage therapies, such as CAR-T in a timely fashion or have already failed these.
2.2 Hodgkin's with one of the following: 2.2.1 Primary refractory (no CR or PD within 3 months) 2.2.2 High-risk relapse, defined as any of the following: CR1 \/= 1 salvage line 2.3 T-non Hodgkin's lymphoma (T-NHL) with one of the following: 2.3.1 Primary refractory (no CR to 1st line) 2.3.2 High-risk relapse (within 6 months) 2.3.3 Refractory relapse to \>/= 1 line of salvage 2.3.4 Any other lymphoma that is refractory or relapsed and that does not qualify for autologous transplant protocols of higher priority.
3. Adequate renal function (creatinine clearance estimated using the Cockcroft-Gault equation of \>/= 51 mL/min: Estimated creatinine clearance = (140-age \[years\]) x weight (kg) (xF)a / serum creatinine (mg/dL) x 72 \[a where F=0.85 for females and F=1 for males.\]
4. Adequate hepatic function (Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) \
Source: ClinicalTrials.gov (NCT03259503). StuddyBuddy aggregates publicly available trial information.