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Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

NCT06192979 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-03-09

No results posted yet for this study

Summary

Achievement of complete hematologic response (CHR) is vital for systemic AL amyloidosis. Currently, the CHR rate of daratumumab, bortezomib, and dexamethasone (DBD) is close to 60%. Considering that Bcl-2 inhibitor is effective for AL amyloidosis with t(11; 14) and the median hematologic onset time of DBD is 7 days. We design a a prospective study on AL amyloidosis with t(11; 14). All patients receive DBD at the beginning. Patient will receive DBD for at least 6 cycles if achieve rapid hematologic response at day 7, while other patients will receive daratumumab, venetoclax and dexamethasone.

Conditions

  • Amyloidosis; Systemic
  • AL Amyloidosis

Interventions

DRUG

Daratumumab

Daratumumab 16 mg/kg was administered intravenously weekly in cycles one and two, every two weeks for cycles three to six, for at least 6 cycles. Daratumumab and hyaluronidase-fihj 1800mg is allowed according to the patients' choice.

DRUG

Bortezomib

All patients received 1.0-1.3 mg/m2 subcutaneous bortezomib once weekly of 28 days each for at 6 cycles.

DRUG

Dexamethasone

All patients received 20-40 mg oral or intravenous dexamethasone

DRUG

Venetoclax

All patients received venetoclax 400mg daily.

Sponsors & Collaborators

  • Jin Lu, MD

    lead OTHER

Principal Investigators

  • Jin Lu · Peking University People's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2026-09-30
Completion
2027-03-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06192979 on ClinicalTrials.gov