## Protocol Section
### Identification Module
**NCT ID:** NCT00038779

**Brief Title:** Blood Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

**Official Title:** Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation for Patients With Hematologic Malignancies or Bone Marrow Failure States

#### Organization Study ID Info
**ID:** DM96-122
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
### Status Module
#### Completion Date
**Date:** 2004-09-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-10-30

**Type:** ACTUAL

**Last Update Submit Date:** 2018-10-29

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2004-09-20

**Type:** ACTUAL

#### Start Date
**Date:** 1996-08-14

**Type:** ACTUAL

**Status Verified Date:** 2018-10

#### Study First Post Date
**Date:** 2002-06-07
**Type:** ESTIMATED
**Study First Submit Date:** 2002-06-05
**Study First Submit QC Date:** 2002-06-06
**Why Stopped:** Lack of Accrual
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to assess early treatment failure within 100 days and to assess the effect of this regimen on engraftment, GVHD, immune recovery, relapse of malignancy and survival.

### Conditions Module

**Conditions:**

- Leukemia

- Non Hodgkin's Lymphoma

- Aplastic Anemia

**Keywords:**

- Lymphoma

- CML

- CLL

- AML

- ALL

- MDS

- AA

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 7

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Procedure: Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

**Label:** Megadose T cell depleted

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Megadose T cell depleted

**Name:** Megadose T-cell Depleted HLA-nonidentical Blood Progenitor Cell Transplantation

**Type:** PROCEDURE

### Eligibility Module

**Eligibility Criteria:** * Patients with acute leukemia, lymphoma that failed to respond or relapsed after chemotherapy or CML beyond first chronic phase.
* Patients with aplastic anemia or myelodysplasia which failed to respond to primary therapy are eligible.
* Patients with low grade lymphoma or CLL will only be eligible if they failed two chemotherapy regimens and have stage IV disease.
* Patients must be \<age 50 with a related haploidentical donor (phenotypically one, two or three HLA A, B and DR antigen mismatched) donor.
* Patients should have adequate hepatic and renal function with a bilirubin of less than or equal to 1.5mg%, SGPT less than or equal to 3x the upper limits of normal, and creatine less than or equal to 1.5mg%.
* Patients with serious intercurrent medical illness are not eligible.
* Patients and their donors must provide written informed consent.

**Maximum Age:** 49 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Houston

**Country:** United States

**Facility:** MD Anderson Cancer Center

**State:** Texas

**Zip:** 77030

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009369

- Term: Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000000740

- Term: Anemia

- ID: D000001855

- Term: Bone Marrow Diseases

- ID: D000095542

- Term: Cytopenia

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10945

- Name: Leukemia

- Relevance: LOW

- As Found: Unknown

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M4071

- Name: Anemia, Aplastic

- Relevance: HIGH

- As Found: Aplastic Anemia

- ID: M4070

- Name: Anemia

- Relevance: LOW

- As Found: Unknown

- ID: M21314

- Name: Hematologic Neoplasms

- Relevance: HIGH

- As Found: Hematologic Malignancies

- ID: M13118

- Name: Pancytopenia

- Relevance: HIGH

- As Found: Bone Marrow Failure

- ID: M2241

- Name: Bone Marrow Failure Disorders

- Relevance: HIGH

- As Found: Bone Marrow Failure

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5134

- Name: Bone Marrow Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3170

- Name: Cytopenia

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T460

- Name: Aplastic Anemia

- Relevance: HIGH

- As Found: Aplastic Anemia

### Condition Browse Module - Meshes

- ID: D000019337

- Term: Hematologic Neoplasms

- ID: D000000741

- Term: Anemia, Aplastic

- ID: D000080983

- Term: Bone Marrow Failure Disorders

- ID: D000010198

- Term: Pancytopenia

### Misc Info Module

- Version Holder: 2024-05-24
