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Clinical Efficacy of MOAP Regimen for Relapsed/Refractory cHL as a Rescue Therapy After DP Regimen

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04026269
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital

Brief Summary:
The DP regimen, low-dose decitabine combined with SHR-1210, is the new treatment for relapsed or refractory classical Hodgkin's Lymphoma. Though the CR rate of this regimen is impressively high, which is verified more than 70% in our I/II phase study, there are also lots of patients cannot benefit from this treatment. On top of that, as the increasing utilization of mono-therapy or combination treatment with the immune checkpoint blockade (ICB), the adverse reactions associated with immunotherapy make it unavailable in parts of patients. The application of MOAP regimen to patients, who have a progressive disease after DP regimen, can bring high CR rate. MOAP can be the a rescue treatment for cHL resisted to DP treatment.

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: MOAP Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of MOAP Regimen for Relapsed/Refractory Classical Hodgkin's Lymphoma as a Rescue Therapy After Ineffective Treatment of Additional Low-dose Decitabine to Anti-PD-1 Antibody Camrelizumab
Estimated Study Start Date : July 30, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MOAP treatment
Chlormethine Hydrochloride Injection 10mg d1,8 iv Vindesine Sulfate for Injection 4mg d1,8 iv Doxorubicin Hydrochloride Injection 25mg/m2 d1,8 iv Prednisone Acetate Tablets 1-1.5mg/kg/d d1-10 po 28 days/Cycle
Drug: MOAP
the new chemotherapy regimen for r/r cHL

Primary Outcome Measures :
  1. CRR assess by investigators per the 2014 Lugano classification [ Time Frame: 3 years ]
    Time measured from the day of first documented PR or CR to the date of first rate of subjects achieved complete response in all evaluable subjects

  2. Number of Subjects with treatment-related adverse events (AEs) [ Time Frame: 2 years ]
    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

  3. duration of CR [ Time Frame: 5 years ]
    Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
  2. 13 to 70 years of age.
  3. ECOG performance of less than 2.
  4. Life expectancy of at least 3 months.
  5. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
  6. Subjects must have received at least two prior chemotherapy regimen and four cycle of DP regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.
  7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

  1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.
  2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.
  3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .
  4. Prior organ allograft.
  5. Women who are pregnant or breastfeeding.
  6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.
  7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

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 identifier (NCT number): NCT04026269

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Contact: Weidong Han 86(10)66937463

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China, Beijing
Biotherapeutic Department of Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Qingming Yang, M.D    +86-10-55499341   
Principal Investigator: Weidong Han, M.D         
Principal Investigator: Qingming Yang, M.D         
Principal Investigator: Chunmeng Wang, M.S         
Principal Investigator: Wenjing Ku, M.S         
Sponsors and Collaborators
Han weidong

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Responsible Party: Han weidong, Principal Investigator, Chinese PLA General Hospital Identifier: NCT04026269     History of Changes
Other Study ID Numbers: CHN-PLAGH-BT-043
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Han weidong, Chinese PLA General Hospital:
MOAP; Relapsed/Refractory; Hodgkin Lymphoma; DP;
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases