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Alkylating Agent

Olaparib + Chemotherapy for Lymphoma

Phase 1

Waitlist Available

Led By Yago L Nieto

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male patients and their partners must agree to the use of two highly effective forms of contraception

Prior apheresis of >/= 3 million CD34+ cells/Kg

Must not have

Prior whole brain irradiation

Active hepatitis B

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing olaparib + high-dose chemotherapy vs. chemotherapy alone in treating patients with lymphomas that have come back or does not treatment and are undergoing stem cell transplant.

Who is the study for?

This trial is for adults aged 18-65 with certain types of relapsed or refractory lymphomas, including T-cell and B-cell non-Hodgkin's lymphoma, Hodgkin's lymphoma, and diffuse large B-cell lymphoma. Participants must have adequate organ function and not be eligible for higher priority transplant protocols. They should not be pregnant or breastfeeding, able to swallow pills, free from serious infections or other health conditions that could affect participation.

What is being tested?

The trial tests the combination of olaparib with high-dose chemotherapy (including vorinostat, gemcitabine, busulfan, melphalan) versus standard treatment in patients undergoing stem cell transplantation. It aims to determine the safety and optimal dosage of olaparib when used alongside these chemotherapeutic agents.

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss (alopecia), blood disorders leading to increased infection risk or bleeding problems. Olaparib may also cause gastrointestinal symptoms like indigestion or diarrhea and increase the risk of developing secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My partner and I agree to use two effective birth control methods.

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I have had a procedure to collect at least 3 million stem cells per kilogram of my body weight.

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I am between 18 and 65 years old.

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My kidneys work well enough (creatinine clearance over 51 mL/min).

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I can do most of my daily activities without help.

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I am postmenopausal or cannot become pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had whole brain radiation before.

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I have active hepatitis B.

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I have severe liver damage due to chronic hepatitis C.

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I am currently on IV antibiotics for an infection.

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I have not had any other cancer in the last 5 years.

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My heart's electrical activity is abnormal, or I have a family history of long QT syndrome.

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I am not taking strong or moderate CYP3A inhibitors.

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I am not taking any strong or moderate drugs that affect liver enzymes.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I have not had major surgery in the last 2 weeks.

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I do not have any uncontrolled diseases or active infections.

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I cannot swallow pills or have stomach issues affecting medication absorption.

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I am able to understand and follow the study's requirements.

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I have brain metastases that are not under control and cause symptoms.

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I have lasting side effects from cancer treatment, but not hair loss.

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I haven't had chemotherapy or radiotherapy in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose limiting toxicities (DLT)

Secondary study objectives

Complete response (CR)

Event-free survival (EFS)

Incidence of adverse events

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (olaparib, high-dose chemotherapy, transplant)Experimental Treatment8 Interventions

Patients receive olaparib PO BID on days -11 to -3, vorinostat PO on days -10 to -3, gemcitabine IV over 4.5 hours on days -9 and -4, busulfan IV over 3 hours on day -9 to -6, melphalan IV over 30 minutes on days -4 and -3, and undergo peripheral blood stem cell transplant IV over 30-60 minutes on day 0. Patients with CD20+ tumors also receive rituximab IV over 3-6 hours on day -10.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Busulfan

2008

Completed Phase 4

~1710