Health TrialsbyHealthPanel

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

ConditionsAmyloidosis; SystemicAL Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorJin Lu, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of systemic AL amyloidosis;

Daratumumab, bortezomib, dexamethasone used in 1st line treatment;

Life expectancy greater than 12 weeks;

HGB ≥70g/L;

Disqualifiers

Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.

Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;

Severe or persistent infection that cannot be effectively controlled;

Presence of severe autoimmune diseases or immunodeficiency disease;

Trial design

Design model

Single group

Treatments tested in this trial

  • Daratumumab

    Drug

    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.

  • Bortezomib

    Drug

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

  • Dexamethasone

    Drug

    All patients received 20-40 mg oral or intravenous dexamethasone

  • Venetoclax

    Drug

    All patients received venetoclax 400mg daily.

Treatment groups

41 Participants
are divided into 2 treatment groups
Group A: Rapid Response GroupOther 3 interventions
Group B: Non-Rapid Response GroupOther 3 interventions

Trial outcomes

Primary outcomes

1

Overall CHR rate at 6 months

Overall complete hematologic response rate at 6 months

Time frame
Overall CHR rate at 6 months

Secondary outcomes

1

Cardiac response at 6 months

Cardiac response at 6 months

Time frame
Cardiac response at 6 months
2

Renal response at 6 months

Renal response at 6 months

Time frame
Renal response at 6 months
3

Hepatic response at 6 months

Hepatic response at 6 months

Time frame
Hepatic response at 6 months
4

Estimated 2-year PFS

Estimated 2-year progression free survival

Time frame
Estimated 2-year PFS

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jin Lu, MD

Lead sponsor

Peking University People's Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now