Description:
This is a phase I/II open label, multi-center study of azacytidine in combination with
standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at
escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on
day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion
will then evaluate efficacy of the combination at the established MTD.
Title
- Brief Title: Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma
- Official Title: Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
0907010513
- NCT ID:
NCT01004991
Conditions
- Diffuse Large B Cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
rituximab | | All patients |
cyclophosphamide | | All patients |
vincristine | | All patients |
doxorubicin | | All patients |
prednisone | | All patients |
azacytidine | | All patients |
Purpose
This is a phase I/II open label, multi-center study of azacytidine in combination with
standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at
escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on
day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion
will then evaluate efficacy of the combination at the established MTD.
Trial Arms
Name | Type | Description | Interventions |
---|
All patients | Experimental | subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP | - rituximab
- cyclophosphamide
- vincristine
- doxorubicin
- prednisone
- azacytidine
|
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically confirmed DLBCL with characteristic immunophenotypic
profiles. Tumor tissue must be confirmed to express the CD20 antigen by flow cytometry
or immunohistochemistry.
- Patients must have at least one site of measurable disease, 1.5 cm in diameter or
greater.
- Patient has not had any previous treatment.
- Stage II (not appropriate for abbreviated chemoimmunotherapy and radiotherapy), III or
IV disease
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients must have laboratory test results within these ranges:
- Absolute neutrophil count > = 1500/mm³
- Platelet count > = 75,000/mm³
- Serum creatinine < = 1.5X upper limit of normal (ULN)
- Total bilirubin < = 1.5X ULN. Higher levels are acceptable if these can be
attributed to active hemolysis or ineffective erythropoiesis.
- AST (SGOT) and ALT (SGPT) < = 2 x ULN
- Disease free of prior malignancies for > = 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
or breast.
- Women of childbearing potential must have a negative serum pregnancy test prior to
azacitidine treatment.
- Women of childbearing potential should be advised to avoid becoming pregnant and men
should be advised to not father a child while receiving treatment with azacitidine.
The effects of azacytidine on the developing human fetus at the recommended
therapeutic dose are unknown. For this reason, women of child-bearing potential and
men must agree to use adequate contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry and for the duration of study participation.
Should a woman become pregnant or suspect she is pregnant while participating in this
study, she should inform her treating physician immediately.
- Age >18 years.
- Ability to understand and the willingness to sign a written informed consent document.
- ECOG performance status of 0-2
Exclusion Criteria:
- Patients must not have any serious medical condition, laboratory abnormality,or
psychiatric illness that would prevent the subject from signing the informed consent
form.
- Patients must not have any condition, including the presence of laboratory
abnormalities, which places the subject at unacceptable risk if he/she were to
participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis B.
- Known central nervous system involvement by lymphoma.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients must not have advanced malignant hepatic tumors.
- Pregnant and lactating women are excluded from the study because the risks to an
unborn fetus or potential risks in nursing infants are unknown.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Complete Response |
Time Frame: | 13 months |
Safety Issue: | |
Description: | Complete Response |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Weill Medical College of Cornell University |
Last Updated
April 10, 2017