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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicities (DLT)

Secondary outcome measures

Complete response (CR)

Event-free survival (EFS)

Incidence of adverse events

+2 more

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

Busulfan

2008

Completed Phase 3

~1120

Olaparib

2007

Completed Phase 4

~2140

Rituximab

1999

Completed Phase 4

~1880

Gemcitabine

2017

Completed Phase 3

~2070

Melphalan

2008

Completed Phase 3

~1500

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Vorinostat

2014

Completed Phase 3

~1600

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,731 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,103 Total Patients Enrolled

Yago L NietoPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

135 Total Patients Enrolled

Media Library

Busulfan (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03259503 — Phase 1

Diffuse Large B-Cell Lymphoma Research Study Groups: Treatment (olaparib, high-dose chemotherapy, transplant)

Diffuse Large B-Cell Lymphoma Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT03259503 — Phase 1

Busulfan (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03259503 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study open to adults aged 18 and older?

"The requisite age range for this medical trial is 18-65 years old."

Answered by AI

What ailment is Olaparib most commonly prescribed for?

"Olaparib is a drug frequently utilized to treat small cell lung cancer, and it can also be used for certain b-cell lymphomas, polyangiomas, or even lymphoma."

Answered by AI

Is there a recruitment period ongoing for participants in this experiment?

"Per the information listed on clinicaltrials.gov, this trial is currently open to enrollment and was initially posted in September of 2019 with its most recent update occurring on September 22nd 2022."

Answered by AI

What is the current status of Olaparib with regards to regulatory approval?

"Based on the available data, the safety of Olaparib is given a score of 1. This evaluation was made with reference to Phase 1 trials that have only provided limited information about both efficacy and security."

Answered by AI

What is the scope of this experiment in terms of patient enrolment?

"Affirmative. Records hosted on clinicaltrials.gov demonstrate that this medical experiment, which was first listed on September 13th 2019, is actively searching for participants. Approximately 30 patients need to be conscripted from 1 trial centre."

Answered by AI

Have any independent studies been conducted involving Olaparib?

"Currently, 1147 clinical trials are researching the potential of Olaparib. Of those active studies, 264 have advanced to Phase 3. These investigations for Olaparib primarily take place in Philadelphia but can be found at 49391 sites around the world."

Answered by AI

Would I qualify to enroll in this experiment?

"This medical experiment is searching for 30 people with lymphoma aged between 18 and 65. Criteria for qualification includes a diffuse large B-cell lymphoma, Hodgkin's disease, T-non Hodgkin's Lymphoma or any other refractory/relapsed form of the cancer that does not qualify for an autologous transplant protocol. Additionally, the patient must have at least 40% left ventricular ejection fraction (LVEF), no uncontrolled arrhythmias or symptomatic cardiac illness and a creatinine clearance estimated using Cockcroft-Gault equation of greater than 51 mL/min as well as 16 weeks"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant

2019. "Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03259503.

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