Overview

A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma

Status:
Active, not recruiting

Trial end date:
2021-11-01

Target enrollment:
0

Participant gender:
All

Summary

There are 2 parts to this study: Part 1 (dose de-escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of lenalidomide in combination with obinutuzumab and CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) that can be given to patients with diffuse large B cell lymphoma. The goal of Part 2 of this clinical research study is learn if the dose of lenalidomide found in Part 1 can help to control the disease. The safety of this drug combination will be studied in both parts.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborators:

Celgene
Genentech, Inc.

Treatments:

Cyclophosphamide
Doxorubicin
Lenalidomide
Liposomal doxorubicin
Obinutuzumab
Prednisone
Thalidomide
Vincristine

Criteria

Inclusion Criteria:

1. Confirmed treatment-naïve de novo CD20+ DLBCL, regardless of cell of origin, with
Stage II-IV disease, or Stage I disease if 6 cycles of chemotherapy are planned.

2. Measurable disease on cross section imaging that is at least 1.5 cm in the longest
diameter and measurable in two perpendicular dimensions

3. Appropriate candidate for systemic immune-chemotherapy such as the standard RCHOP21 6
cycles as determined by the treating physician

4. Age >/=18

5. Adequate organ function (normal cardiac ejection fraction of >45%, serum bilirubin
<1.5 mg/dl, AST or ALT 30 mL/min (Calculated
according to Cockcroft - Gault formula) unless due to lymphoma with documentation of
normal function prior to onset of lymphoma. In the case of Gilberts Syndrome, or
documented liver or pancreatic involvement by lymphoma, the requirement for total
bilirubin is
6. ANC >1000/mm3, hemoglobin >8.0, and platelets >100,000/mm3. If bone marrow is involved
with lymphoma and normal marrow function prior to onset of lymphoma is documented: ANC
of >750, any hemoglobin, and platelets of >50,000/mm3.

7. Performance status <3 (unless previous performance status was 0 or 1 and deterioration
is due to lymphoma which treating MD expects to reverse with therapy)

8. Consent to potential need for transfusion of blood products

9. Able to give informed consent

10. Ability and willingness to comply with the requirements of the study protocol

Exclusion Criteria:

1. Prior history of low grade lymphoma with transformation to DLBCL. If a patient has a
composite diagnosis of DLBCL and low grade without a prior history of lymphoma, they
will not be considered ineligible.

2. Pregnant or lactating females

3. Symptomatic CNS lymphoma involvement

4. Significant comorbidity (cirrhosis, severe coronary artery disease, significant
psychiatric illness, or other that may compromise the ability to safely administer the
therapy at the discretion of the primary investigator)

5. HBV: Patients with positive serology for Hepatitis B defined as positivity for HBsAg
or anti-HBc. Patients who are positive for anti-HBc may be considered for inclusion in
the study on a case-by-case basis if they are hepatitis B viral DNA negative and are
willing to undergo ongoing HBV DNA testing by real-time PCR. Patients with positive
serology may be referred to a hepatologist or gastroenterologist for appropriate
monitoring and management.

6. Hepatitis C (HCV): Patients with positive hepatitis C serology unless HCV RNA is
confirmed negative and may be considered for inclusion in the study on a case-by-case
basis.

7. Known HIV or HTLV infection

8. Previous malignancy with diagnosis or suspicion of recurrence within the past 2 years,
not including non-melanoma skin cancers or in situ malignancies.

9. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

10. Known hypersensitivity to any of the study drugs

11. Known active bacterial, viral, fungal, mycobacterial, or other infection (excluding
fungal infections of nail beds) or any major episode of infection requiring treatment
with IV antibiotics or hospitalization (related to the completion of the course of
antibiotics) within 4 weeks before the start of Cycle 1

12. Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis

13. Fertile men or women of childbearing potential unless 1) surgically sterile or 2)
using an adequate measure of contraception such as oral contraceptives, intrauterine
device, or barrier method of contraception in conjunction with spermicidal jelly.

14. Effective contraception is required while receiving obinutuzumab. For women, effective
contraception is required to continue for >/= 12 months after the last dose of
obinutuzumab. For men, effective contraception is required to continue for 3 months
after the last dose of obinutuzumab treatment.

15. Vaccination with a live vaccine a minimum of 28 days prior to the start of treatment

16. Peripheral neuropathy >/= Grade 2

17. Subjects who are unwilling to take VTE prophylaxis