Azacitidine With Rituximab, Vincristine, and Cyclophospha... | NCT00901069

Studies
Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma

NCT00901069

Sponsor

Shams Shakil

Status

Completed

Last Update Posted

Oct 17, 2016Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Lymphoma
Hodgkin Disease
Lymphoma, Non-Hodgkin

Interventions

Azacitidine with rituximab, vincristine, and cyclophosphamide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

May 11, 2009

First Submission Date that Met QC Criteria

May 12, 2009

First Posted Date

May 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 13, 2016

Last Update Posted Date

Oct 17, 2016Estimated

Name	Class
Celgene	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azacitidine	Other		Drug: Azacitidine with rituximab, vincristine, and cyclophosphamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azacitidine with rituximab, vincristine, and cyclophosphamide	Drug	Azacitidine cycle days 1-5 Cyclophosphamide cycle days 6-9 Vincristine cycle day 8 Rituximab cycle day 8 Rituximab is only for those patients with CD20+ lymphoma. Azacitidine 25 mg/m2^ Azacitidine 50 mg/m2^ Azacitidine 75 mg/m2^ Azacitidine 100 mg/m2^

Measure	Description	Time Frame
Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma		Eight 21 day cycles

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
Age ≥ 18 years and without a maximum age.
All patients of reproductive potential should not plan on conceiving children during the treatment program and must agree to use a medically accepted form of contraception.
Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of beginning treatment.
Patients must have relapsed lymphoma.
ECOG performance status of 2 or better.

Exclusion Criteria:

Pregnant or breast-feeding at the time of proposed study entry
Clinical AIDS or ARS or known positive HIV serology
History of malignant neoplasm, other than lymphoma, treated within two years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or metastatic disease
Psychiatric or additive disorders that would preclude obtaining informed consent
Serum bilirubin > 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these are attributed to active hemolysis
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels > 2 times ULN
Serum creatinine levels > 1.5 times ULN
Platelets < 75,000/mm3
Absolute neutrophil count < 1500/mm3
Active infection including viral hepatitis
Known or suspected hypersensitivity to mannitol, azacitidine, or rituximab
Grade 3 or 4 neuropathy
Advanced hepatic tumors
Uncompensated heart failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

ID	Term
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine
D011741	Pyrimidine Nucleosides

ID	Term
D008223	Lymphoma
D006689	Hodgkin Disease
D008228	Lymphoma, Non-Hodgkin

ID	Term
D001374	Azacitidine
D000069283	Rituximab
D014750	Vincristine
D003520	Cyclophosphamide