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

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

Sponsors

Lead Sponsor: Han weidong

Source 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.

Overall Status Recruiting
Start Date July 30, 2019
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
CRR assess by investigators per the 2014 Lugano classification 3 years
Number of Subjects with treatment-related adverse events (AEs) 2 years
duration of CR 5 years
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: MOAP

Description: the new chemotherapy regimen for r/r cHL

Arm Group Label: MOAP treatment

Eligibility

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.

Gender: All

Minimum Age: 13 Years

Maximum Age: 70 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Weidong Han

Phone: 86(10)66937463

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Biotherapeutic Department of Chinese PLA General Hospital Qingming Yang, M.D +86-10-55499341 [email protected] Weidong Han, M.D Principal Investigator Qingming Yang, M.D Principal Investigator Chunmeng Wang, M.S Principal Investigator Wenjing Ku, M.S Principal Investigator
Location Countries

China

Verification Date

July 2019

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Chinese PLA General Hospital

Investigator Full Name: Han weidong

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: MOAP treatment

Type: Experimental

Description: 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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov