Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Un… (NCT03259503) | Clinical Trial Compass
CompletedPhase 1
Olaparib and High-Dose Chemotherapy in Treating Patients With Relapsed or Refractory Lymphomas Undergoing Stem Cell Transplant
United States50 participantsStarted 2019-09-13
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-65
. Patients with:
.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 \<6 mo, secondary IPI \>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 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 year, extranodal relapse, or B symptoms.
.2.3 Refractory relapse: No response to \>/= 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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 \[a where F=0.85 for females and F=1 for males.\]
. Adequate hepatic function (Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT)) \</= 3.5 x institutional upper limit of normal unless liver metastases or a systemic inflammatory picture secondary to the lymphoma are present in which case they must be \</= 6x ULN; total bilirubin \</= 2.5 x ULN or \</= 3.5 x ULN if Gilbert's disease)
. Prothrombin time (PT) \</=1.5 x institutional upper limit of normal
Exclusion criteria
. Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
. Prior whole brain irradiation
. Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA \>/= 10,000 copies/mL, or \>/= 2,000 IU/mL)
. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology
. Active infection requiring parenteral antibiotics
. Patients who are known to be serologically positive for human immunodeficiency virus (HIV).
. Patients receiving any systemic chemotherapy or radiotherapy (except for palliative reasons) within 3 weeks prior to study treatment