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

NCT ID: NCT04026269

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2020-12-31

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.

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

MOAP

Intervention Type: DRUG

the new chemotherapy regimen for r/r cHL

Interventions

MOAP

the new chemotherapy regimen for r/r cHL

Intervention Type: DRUG

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Han weidong

OTHER

Sponsor Role: lead

Responsible Party

Han weidong

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Biotherapeutic Department of Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Weidong Han

Role: CONTACT

hanwdrsw@sina.com

86(10)66937463

Facility Contacts

Qingming Yang, M.D

Role: primary

yangqm@medmail.com.cn

+86-10-55499341

Other Identifiers

CHN-PLAGH-BT-043

Identifier Type: -

Identifier Source: org_study_id