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

Sponsor

Han weidong (Other)

Overall Status

Unknown status

CT.gov ID

NCT04026269

Collaborator

(none)

Enrollment

Location

Arm

17.1

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jul 30, 2019

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 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

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

CRR assess by investigators per the 2014 Lugano classification [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) [2 years]
Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.
duration of CR [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

Criteria

Ages Eligible for Study:

13 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).
13 to 70 years of age.
ECOG performance of less than 2.
Life expectancy of at least 3 months.
Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.
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.
Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing	China	100853

Sponsors and Collaborators

Han weidong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Han weidong, Principal Investigator, Chinese PLA General Hospital

ClinicalTrials.gov Identifier:

NCT04026269

Other Study ID Numbers:

CHN-PLAGH-BT-043

First Posted:

Jul 19, 2019

Last Update Posted:

Jul 19, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Han weidong, Principal Investigator, Chinese PLA General Hospital

MOAP; Relapsed/Refractory; Hodgkin Lymphoma; DP;

Additional relevant MeSH terms:

Lymphoma

Hodgkin Disease

Study Results

No Results Posted as of Jul 19, 2019