CompletedPhase 1/2

Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL

United States18 participantsStarted 2010-10

Plain-language summary

The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival. Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival.

Who can participate

Age range18 Years

SexALL

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 years at the time of signing the informed consent form.
✓. Able to adhere to the study visit schedule and other protocol requirements.
✓. Histologically confirmed diffuse large B cell lymphoma
✓. Relapsed or refractory after one prior therapeutic treatment for DLBCL. Refractory is defined as patients received adequate prior treatment and did not respond during treatment or progressed within 90 days of last treatment.
✓. Measurable disease with at least on bidimensional lymph node or tumor mass \>1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
✓. Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease
✓. Eligible for autologous stem cell transplant
✓. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study.

Exclusion criteria

What they're measuring

Stage I - Safety (Type, Frequency, Severity and Relationship of Adverse Events to Study Treatment) and Tolerability

Timeframe: Cycle 1 of Treatment (28 Days)

Stage II - Overall Response Rate

Timeframe: After 2 Cycles of Treatment (28 Day Cycles)

Stage III - Overall Response Rate

Timeframe: After 2 Cycles of Treatment (28 Day Cycles)

Trial details

NCT IDNCT01241734

SponsorHackensack Meridian Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

Results submitted2021-10-07

View on ClinicalTrials.gov More Diffuse Large B Cell Lymphoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

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 years at the time of signing the informed consent form.
✓. Able to adhere to the study visit schedule and other protocol requirements.
✓. Histologically confirmed diffuse large B cell lymphoma
✓. Relapsed or refractory after one prior therapeutic treatment for DLBCL. Refractory is defined as patients received adequate prior treatment and did not respond during treatment or progressed within 90 days of last treatment.
✓. Measurable disease with at least on bidimensional lymph node or tumor mass \>1.5 cm in the longest diameter that can be followed for response as a target lesion as measured by PET or CT
✓. Histologically confirmed involvement of the bone marrow by DLBCL on the bone marrow biopsy without other measurable disease
✓. Eligible for autologous stem cell transplant
✓. All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least two weeks prior to treatment in this study.

Exclusion criteria

What they're measuring

Stage I - Safety (Type, Frequency, Severity and Relationship of Adverse Events to Study Treatment) and Tolerability

Timeframe: Cycle 1 of Treatment (28 Days)

Stage II - Overall Response Rate

Timeframe: After 2 Cycles of Treatment (28 Day Cycles)

Stage III - Overall Response Rate

Timeframe: After 2 Cycles of Treatment (28 Day Cycles)