Decitabine Plus R-CHOP in Diffuse Large B-cell Lymphoma

NCT02951728 | Unknown Phase 1 DMC

• 1 other identifier: DR-CHOP
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• maximum tolerated dose

  The primary endpoint for the phase I portion of the study is to determine the maximum tolerated dose of Decitabine when given in combination with a standard dose (q21 day) regimen of R-CHOP in patients with DLBCL.

  day1 to 21

• complete response rate

  The primary endpoint for the phase II portion of the study will be complete response rate.

  21 days after 6 cycles of treatment (each cycle is 21 days)

Secondary Outcomes (5)

• Overall response rate

  21 days after 6 cycles of treatment (each cycle is 21 days)

• Event-free survival

  2 years

• Overall survival

  2 years

• Progression-free survival

  2 years

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

  Up to 30 days after completion of study treatment

Study Arms (1)

Decitabine plus R-CHOP

EXPERIMENTAL

Rituximab 375 mg/m2 IV d6; Cyclophosphamide 750mg/m2 IV d7; Doxorubicin 50mg/m2 IV d7; Vincristine 1.4 mg/m2 IV d7; Prednisone 60 mg/m2 PO d7-11; Decitabine will be administered intravenously at dose levels as follow in Phase 1: Dose level 1: Decitabine 10 mg/m2 days 1-5; Dose level 2: Decitabine 15 mg/m2 days 1-5; Dose level 3: Decitabine 20 mg/m2 days 1-5 and determine the maximum tolerated dose. In phase 2, Decitabine will be administered intravenously at MTD.

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Decitabine

Interventions

Rituximab DRUG

Decitabine plus R-CHOP

Cyclophosphamide DRUG

Decitabine plus R-CHOP

Doxorubicin DRUG

Decitabine plus R-CHOP

Vincristine DRUG

Decitabine plus R-CHOP

Prednisone DRUG

Decitabine plus R-CHOP

Decitabine DRUG

Decitabine plus R-CHOP

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed DLBCL, CD20 positive.
• must have at least one site of measurable disease, 1.5 cm in diameter or greater.
• has not had any previous treatment.
• International Prognostic Index \>1.
• Able to adhere to the study visit schedule and other protocol requirements.
• must have laboratory test results within these ranges: Absolute neutrophil count ≥1500/mm3 Platelet count≥75,000/mm3 Serum creatinine≤1.5×upper limit of normal (ULN) Total bilirubin≤1.5×ULN. Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
• AST (SGOT) and ALT (SGPT) ≤2×ULN
• Disease free of prior malignancies 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 Decitabine 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 Decitabine. The effects of Decitabine 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 15 to 75 years.
• Ability to understand and the willingness to sign a written informed consent document.
• ECOG performance status of 0-2

You may not qualify if:

• 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. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA, DNA positive patients cannot be enrolled.
• Known central nervous system involvement by lymphoma.
• Known or suspected hypersensitivity to Decitabine or mannitol.
• Pregnant and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, 20025, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Decitabine

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Azacitidine; Aza Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Weili Zhao, MD，PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: October 1, 2020
• Last Updated: March 11, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)