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Decitabine Plus R-CHOP in Diffuse Large B-cell Lymphoma (DR-CHOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951728
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

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

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Decitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma
Study Start Date : October 2016
Actual Primary Completion Date : May 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Decitabine

Arm Intervention/treatment
Experimental: Decitabine plus R-CHOP

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



Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: day1 to 21 ]
    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.

  2. complete response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ]
    The primary endpoint for the phase II portion of the study will be complete response rate.


Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ]
  2. Event-free survival [ Time Frame: 2 years ]
  3. Overall survival [ Time Frame: 2 years ]
  4. Progression-free survival [ Time Frame: 2 years ]
  5. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Up to 30 days after completion of study treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951728


Locations
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China
Shanghai Ruijin Hospital
Shanghai, China, 20025
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Weili Zhao, MD,PhD Shanghai Jiao Tong University School of Medicine
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Responsible Party: Zhao Weili, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT02951728    
Other Study ID Numbers: DR-CHOP
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
Decitabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors