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出境医 / 临床实验 / Clinical Efficacy of MOAP Regimen for Relapsed/Refractory cHL as a Rescue Therapy After DP Regimen

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

Study Description
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
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
Arms and Interventions
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
Outcome Measures
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.


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations

Contacts
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Contact: Weidong Han 86(10)66937463 hanwdrsw@sina.com

Locations
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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    yangqm@medmail.com.cn   
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
Tracking Information
First Submitted Date  ICMJE July 18, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date July 19, 2019
Estimated Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Efficacy of MOAP Regimen for Relapsed/Refractory cHL as a Rescue Therapy After DP Regimen
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hodgkin Lymphoma
Intervention  ICMJE Drug: MOAP
the new chemotherapy regimen for r/r cHL
Study Arms  ICMJE 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
Intervention: Drug: MOAP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Weidong Han 86(10)66937463 hanwdrsw@sina.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04026269
Other Study ID Numbers  ICMJE CHN-PLAGH-BT-043
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Study Protocol
Responsible Party Han weidong, Chinese PLA General Hospital
Study Sponsor  ICMJE Han weidong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese PLA General Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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